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APO-BENZYDAMINE ORAL RINSE DIN 02239044

Status: Cancelled Post Market
Holder: APOTEX INC
Molecule: BENZYDAMINE HYDROCHLORIDE

Health Canada record

Active ingredient(s)BENZYDAMINE HYDROCHLORIDE 0.15 %
Dosage formMouthwash/Gargle
RouteBuccal
SchedulePRESCRIPTION
ClassHuman
ATCA01AD02 BENZYDAMINE
Original market date09-Nov-1998
Current status date17-Apr-2025
SourceHealth Canada DPD

Establishment licence of the holder

Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-04-21).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing BENZYDAMINE HYDROCHLORIDE

DINProductCompanyFormStrengthStatus
02463105ODAN-BENZYDAMINEODAN LABORATORIESLTDMouthwash/GargleBENZYDAMINE HYDROCHLORIDE 0.15 %Marketed
02229777PHARIXIAPENDOPHARM DIVISION OF PHARMASCIENCE INCMouthwash/GargleBENZYDAMINE HYDROCHLORIDE 0.15 %Marketed
02494434PHARIXIA ALCOHOL FREEPENDOPHARM DIVISION OF PHARMASCIENCE INCMouthwash/GargleBENZYDAMINE HYDROCHLORIDE 0.15 %Marketed
02239537PMS-BENZYDAMINEPHARMASCIENCE INCMouthwash/GargleBENZYDAMINE HYDROCHLORIDE 0.15 %Marketed
02310422NOVO-BENZYDAMINENOVOPHARM LIMITEDMouthwash/Gargle; SolutionBENZYDAMINE HYDROCHLORIDE 1.5 MGCancelled Post Market
02229799NOVO-BENZYDAMINE - ORAL RINSENOVOPHARM LIMITEDLiquid; Mouthwash/GargleBENZYDAMINE HYDROCHLORIDE 1.5 MGCancelled Post Market
02238794NU-BENZYDAMINE ORAL RINSENU-PHARM INCLiquidBENZYDAMINE HYDROCHLORIDE 0.15 %Cancelled (Unreturned Annual)
02230170RATIO-BENZYDAMINERATIOPHARM INC DIVISION OF TEVA CANADA LIMITEDSolutionBENZYDAMINE HYDROCHLORIDE 0.15 %Cancelled Post Market
01966065TANTUMBAUSCH HEALTH, CANADA INC.Mouthwash/GargleBENZYDAMINE HYDROCHLORIDE 0.15 %Dormant

Notices of Compliance

NOCDateSubmissionReason
27071998-11-09Abbreviated New Drug Submission (ANDS)

International API supply for BENZYDAMINE HYDROCHLORIDE

3 valid EDQM Certificates of Suitability from 3 holders.

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